Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes

Last updated: January 13, 2026
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Treatment

Automated closed-loop insulin delivery

Clinical Study ID

NCT07240012
3080181
  • Ages 18-45
  • Female

Study Summary

A national multi-center open-label randomized controlled trial that investigates whether the use of the automated insulin delivery system CamAPS FX initiated during pregnancy planning or in early pregnancy improves maternal time in glycemic targets and fetal growth in women with type 1 diabetes compared to usual insulin treatment modality combined with Continuous Glucose Monitoring.

Eligibility Criteria

Inclusion

Inclusion criteria during pregnancy planning

  • Women, age 18-45 years

  • Duration of type 1 diabetes ≥ 12 months

  • Women who are not pregnant confirmed by a negative pregnancy test on the day of randomization

  • Planning pregnancy within 52 weeks

Inclusion during pregnancy:

  • Women, age 18-45 years

  • Duration of type 1 diabetes ≥ 12 months

  • Pregnant with an intrauterine singleton living fetus confirmed by an ultrasound scan between 8+0 and 13+6 gestational weeks

  • Accepting participation in the DDBR2 study during pregnancy, delivery and until one month after delivery

Exclusion criteria during pregnancy planning and during pregnancy:

  • No proficiency in Danish to understand oral and written information

  • Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator

Study Design

Total Participants: 305
Treatment Group(s): 1
Primary Treatment: Automated closed-loop insulin delivery
Phase:
Study Start date:
December 01, 2025
Estimated Completion Date:
October 31, 2028

Study Description

This is a national multi-center open-label randomized controlled trial investigating whether the use of the automated insulin delivery system CamAPS FX initiated during pregnancy planning or in early pregnancy (<14 completed weeks) improves maternal glycemic control in women with type 1 diabetes during pregnancy, delivery and post-delivery and leads to more appropriate fetal growth compared to usual insulin treatment modality (multiple day injections or insulin pump) combined with continuous glucose monitoring.

Women planning pregnancy will initiate the automated insulin delivery system CamAPS FX or continue usual insulin treatment modality combined with a compatible continuous glucose monitoring, as per randomisation allocation before conception and throughout pregnancy until one month post-delivery or for up to 52 weeks if not becoming pregnant. Women who become pregnant during the 52-week study period will be referred to their local center for pregnant women with diabetes and followed during pregnancy until one month post-delivery. Women who do not become pregnant during the 52-week study period will leave the study and continue usual diabetes care at their usual diabetes center.

Women who are pregnant at randomisation will initiate the automated insulin delivery system CamAPS FX or continue usual insulin treatment modality combined with a compatible continuous glucose monitoring as per randomisation allocation, throughout the pregnancy period until one month post-delivery.

Connect with a study center

  • Department of Gynecology and Obstetrics, Aalborg University Hospital

    Aalborg 2624886, Aalborg 9000
    Denmark

    Active - Recruiting

  • Department of Gynecology and Obstetrics, Aarhus University Hospital

    Aarhus 2624652, Aarhus N 8200
    Denmark

    Site Not Available

  • Steno Diabetes Center Aarhus

    Aarhus 2624652, Aarhus N 8200
    Denmark

    Site Not Available

  • Steno Diabetes Center Nordjylland

    Aalborg 2624886, Gistrup 9260
    Denmark

    Active - Recruiting

  • Steno Diabetes Center Copenhagen

    Copenhagen 2618425, Herlev 2730
    Denmark

    Site Not Available

  • Department of Gynecology and Obstetrics, Odense University Hospital

    Odense 2615876, Odense C 5000
    Denmark

    Active - Recruiting

  • Steno Diabetes Center Odense, Odense University Hospital

    Odense 2615876, Odense C 5000
    Denmark

    Active - Recruiting

  • Center for Pregnant Women with Diabetes, Rigshospitalet

    Copenhagen 2618425, 2100
    Denmark

    Active - Recruiting

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